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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tube, aspirating, flexible, connecting
Product CodeBYY
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2015 2 2
2016 20 20
2017 34 34
2018 12 12
2019 18 18
2020 23 23
2021 11 11
2022 11 11
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Delivered as Unsterile Product 74 74
Device Packaging Compromised 21 21
Packaging Problem 19 19
Unsealed Device Packaging 13 13
Device Contamination with Chemical or Other Material 4 4
Material Integrity Problem 2 2
Detachment of Device or Device Component 2 2
Detachment Of Device Component 2 2
Break 1 1
Physical Resistance/Sticking 1 1
Device Damaged Prior to Use 1 1
Suction Failure 1 1
Kinked 1 1
Defective Device 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Decrease in Suction 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unexpected Color 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1
Insufficient Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 72 72
No Clinical Signs, Symptoms or Conditions 37 37
Not Applicable 21 21
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 4 4
No Information 1 1
Unspecified Immune System Problem 1 1
Insufficient Information 1 1
Bacterial Infection 1 1

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